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Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)

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ClinicalTrials.gov Identifier: NCT05121545
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.

Condition or disease Intervention/treatment Phase
Sarcoma Melanoma Radiation: Pro-GRID Not Applicable

Detailed Description:

The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques.

In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern.

In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single arm phase I study design, evaluating the feasibility (primary endpoint), toxicity (secondary endpoint), and degree of response (exploratory endpoint) after proton GRID therapy in patients with bulky tumors.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)
Actual Study Start Date : April 6, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024


Arm Intervention/treatment
Pro-GRID treatment Arm
Patients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction.
Radiation: Pro-GRID
Study participants will receive a single treatment of Pro-GRID therapy. After which, the participants would be able to resume standard therapy (after one week) and receive additional radiotherapy one month after Pro-GRID therapy, if recommended. Participants will be in the study for one year. Follow-up appointments will be scheduled at 1, 3, 6 and 12 months posttreatment, and may include a history and physical exam, labs and/or a CT scan and toxicity assessments.
Other Name: Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRID




Primary Outcome Measures :
  1. Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants [ Time Frame: 1.5 years ]
    To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.


Secondary Outcome Measures :
  1. Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4) [ Time Frame: 3 months post-treatment ]
    To determine the rate of mild acute toxicity, defined as any CTCAE grade 2 or lower toxicity, and severe acute toxicity, defined as any CTCAE grade 3 or higher toxicity.

  2. Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy [ Time Frame: 1, 6 and 12 months post-treatment ]
    To determine the change in response rate for bulky tumors treated and not treated with Proton GRID by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.

  3. Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy [ Time Frame: 1, 6 and 12 months post-treatment ]
    Change in degree of treatment response would be measured by RECIST criteria (partial response, complete response, stable disease, or progression of disease).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Histologically or cytologically confirmed invasive cancer
  • Bulky tumor > 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
  • Treated indicated for palliative intent
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2
  • Anticipated treatment deemed safe on pre-review by PI
  • For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID
  • Willing and able to provide informed consent
  • Discussion with medical oncology or surgical specialty

Exclusion Criteria:

  • Age < 18
  • ECOG performance status 3-4
  • Planned for definitive, curative management
  • For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
  • Tumor encasing critical structure, as defined by the treating MD.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05121545


Contacts
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Contact: Jean Wright, MD 410-502-6795 jwrigh71@jhmi.edu
Contact: Dana Kaplin, MPH 410-502-6795 dkaplin1@jhmi.edu

Locations
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United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Jean Wright, MD    202-537-4788    jwrigh71@jhmi.edu   
Contact: Aditya Halthore, MD       ahaltho1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Jean Wright, MD Radiation Oncology, SOM
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT05121545    
Other Study ID Numbers: J2161
IRB00289810 ( Other Identifier: JHM IRB )
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Spatially-fractionated radiotherapy
GRID-therapy
Proton therapy
Sarcoma
Melanoma
Treatment resistant tumors
Additional relevant MeSH terms:
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Melanoma
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue